On October 2, 2023 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported the Pre-IND meeting requested on September 8th for HT-KIT with the U.S. Food and Drug Administration (FDA) has been granted to receive written responses only from the FDA that are targeted for delivery on November 7, 2023 (Press release, Hoth Therapeutics, OCT 2, 2023, View Source [SID1234635579]).

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HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting and already has Orphan Drug Designation from the FDA.

The Pre-IND meeting topics include the acceptability of the overall proposed drug development program for HT-KIT including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls. The proposed clinical trial designs for the first clinical studies in the HT-KIT program are also included in the Pre-IND meeting topics to receive FDA feedback.

"We are looking forward to receiving feedback from the FDA to continue advancing the HT-KIT program towards the clinic as efficiently as possible," stated Robb Knie, Chairman and CEO of Hoth Therapeutics. "Receiving feedback from the FDA in November positions us well to achieve our planned IND-enabling development activities on time with the eventual goal of initiating the first HT-KIT clinical trial in patients."